FDA 510(k)

TEMPEDY

Número K: K152946 · 2016-09-15

Data da decisão2016-09-15

Código do produtoNCX

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

TEMPEDY is the device name listed in this FDA 510(k) record. The listed applicant is Seiratherm GmbH. It received FDA 510(k) clearance on 2016-09-15 under 510(k) number K152946. The device is classified under product code NCX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the TEMPEDY?

TEMPEDY is a medical device that received FDA 510(k) clearance on 2016-09-15. The listed applicant is Seiratherm GmbH. The 510(k) number is K152946.

When did TEMPEDY receive FDA 510(k) clearance?

TEMPEDY received FDA 510(k) clearance on 2016-09-15, under 510(k) number K152946.

Who is the listed applicant for TEMPEDY?

The FDA 510(k) record lists Seiratherm GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TEMPEDY?

The FDA product code for TEMPEDY is NCX.

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Dispositivos Relacionados (Código: NCX)

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